BS EN ISO 20184-1:2018 pdf free download.Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue. This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15189:2012. Medical laboratories — Requirements for quality and competence 3 Terms and definitions For the…

BS EN ISO 20184-1:2018 pdf free.Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue Part 1: Isolated RNA. For general statements on medical laboratory quality management systems and in particular on specimen collection, reception and handling (including avoidance of cross contaminations) see ISO 15189:2012, 4.2, 5.4.4, 5.4.6 or ISO/IEC 17020:2012， Clause 8 and 7.2. The requirements on laboratory equipment, reagents, and consumables in accordance with ISO 15189:2012, 5.3 shall be followed; ISO 15189:2012, 5.5.1.2 and 5.5.1.3, and ISO/IEC 17020:2012, 6.2 can also apply. All steps of a diagnostic workilow can influence the final analytical test result. Thus, the entire workf low including biomolecule stability and sample storage conditions shall be verified and validated. Workflow steps which cannot always be controlled (e.g. warm ischemia) shall be documented. A risk assessment of non-controllable workflow steps including their potential impact on the analytical test performance shall be performed and mitigation measures shall be established to enable the required analytical test performance. Before or during the design of an analytical test, it should therefore be investigated and assured that the RNA profile(s) intended to be analysed is/are not compromised in a manner impacting the analytical test performance (e.g. by performing…